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Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease

NCT04818892 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 222

Last updated 2022-12-07

No results posted yet for this study

Summary

The overall objective of this proposal is to evaluate the safety and immunogenicity of a COVID-19 vaccine in patients with Inflammatory Bowel Disease (IBD). This will help determine if immunosuppressive regimens impact COVID-19 vaccine response. The investigators will determine if certain groups may need more doses of a vaccine, with future adjuvanted vaccines or require a booster to maintain immunity. 260 participants with IBD and scheduled to get a COVID-19 vaccine will be recruited and can expect to be on study for 18 months.

Conditions

  • IBD
  • Covid19 Vaccine

Interventions

DIAGNOSTIC_TEST

Serological Assay for SARS-CoV-2

LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Freddy Caldera, DO, MS · UW School of Medicine and Public Health

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2022-11-11
Completion
2022-11-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818892 on ClinicalTrials.gov